federal_register: 2021-25374

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2021-25374 Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assay Devices, Renamed to Hepatitis C Virus Antibody Tests Rule The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV, postamendments class III devices (product code MZO) into class II (general controls and special controls), subject to premarket notification. FDA is renaming and codifying these devices under the classification regulation named "hepatitis C virus (HCV) antibody tests." FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices. 2021-11-22 2021 11 https://www.federalregister.gov/documents/2021/11/22/2021-25374/microbiology-devices-reclassification-of-certain-hepatitis-c-virus-antibody-assay-devices-renamed-to https://www.govinfo.gov/content/pkg/FR-2021-11-22/pdf/2021-25374.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV, postamendments class III devices (product code MZO) into...  

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